Intravitreal Celecoxib for Chronic Uveitis: A Phase I Investigational Safety Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 主要终点
- Safety
研究概览
简要总结
Intraocular delivery of celecoxib will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects.
详细描述
Specific Aims I: Test the safety of intraocular injection of 1mg and 4mg celecoxib in patients who have chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects.
II: Test the efficacy of intraocular 1mg and 4mg celecoxib in treating inflammation or structural complications of inflammation (macular edema) in patients who are unable to tolerate corticosteroids due to their side effects.
After investigational new drug application and Vanderbilt Institutional Review Board approval, celecoxib will be compounded by the Investigational Drug Service of the Vanderbilt Medical Center and packaged in individual sterile single use syringes for intraocular injection within 2 hours of preparation. Pharmaceutical grade celecoxib will be obtained from the drug manufacturer (Pfizer) with certificate analysis and compounded in sterile dimethyl sulfoxide following strict sterile technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic inflammation and/or macular edema despite maximal medical treatment Unable to tolerate corticosteroids due to side effects Aphakic or Pseudophakic subjects
排除标准
- •15 years or younger Have active ocular infection Pregnancy Phakic subjects
研究组 & 干预措施
Celecoxib
1-4 mg intravitreal injection ofCelecoxib
干预措施: Intravitreal Celecoxib (Drug)
结局指标
主要结局
Safety
时间窗: 12 weeks
Participant will receive an intravitreal injection of the Celecoxib and be followed for any possible adverse events
次要结局
- Efficacy(12 weeks)
研究者
Stephen J. Kim, MD
Assistant Professor of Ophthalmology
Vanderbilt University